RecruitingNCT07009873

Clinical Application of Wearable Ultrasound Sensors

Clinical Application on the R&D Purpose of Wearable Ultrasound Sensors:A Single-Center Prospective Study


Sponsor

Chinese PLA General Hospital

Enrollment

300 participants

Start Date

Aug 15, 2025

Study Type

OBSERVATIONAL

Conditions

Summary

This study aims to develop and evaluate a wearable ultrasound imaging sensor for the early diagnosis and real-time monitoring of various diseases, such as cardiovascular conditions and structural abnormalities of superficial organs. With advancements in medical technology, wearable devices have attracted increasing attention for their portability and real-time capabilities.


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Inclusion Criteria7

  • Age ≥ 18 yrs and able to consent
  • Relevant diagnosis for study arm (heart failure, lower-limb DVT, or ICU monitoring)
  • Adequate acoustic window and intact skin at sensor site
  • Arm-specific:
  • Heart-failure arm: Clinically stable HFrEF or HFpEF on standard therapy
  • DVT arm: Imaging-confirmed lower-limb DVT, anticoagulated or scheduled for intervention
  • ICU arm: ICU/post-op patient requiring continuous bedside ultrasound

Exclusion Criteria7

  • Poor acoustic window preventing interpretable images
  • Local skin infection, open wound, or implant/hardware blocking sensor
  • Inability to cooperate with monitoring
  • Arm-specific:
  • Heart-failure arm: Acute MI or uncontrolled arrhythmia in past 3 months
  • DVT arm: Active bleeding or severe coagulopathy
  • ICU arm: Unstable multi-organ failure precluding safe monitoring

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Interventions

OTHERThis study is designed to assess the non-inferiority of a novel ultrasound imaging technique, rather than to evaluate a therapeutic intervention.

This study is designed to assess the non-inferiority of a novel ultrasound imaging technique, rather than to evaluate a therapeutic intervention.


Locations(1)

Chinese PLA General Hospital

Beijing, Beijing Municipality, China

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NCT07009873


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